- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03167658
The Impact of Employee Wellness Programs
September 7, 2021 updated by: Zirui Song, Harvard School of Public Health (HSPH)
There is great public and private interest in the use of workplace wellness programs to reduce health care spending, improve health outcomes, and enhance productivity for employees.
However, there is little rigorous evidence on the effects of wellness programs.
This study partners with a large multi-state U.S. employer (BJ's Wholesale Club) and an experienced wellness vendor (Wellness Workdays) to evaluate a multi-prong workplace wellness program, including components such as nutrition counseling, fitness challenges, and stress management workshops.
The wellness program will be delivered by a team of experts including Registered Dieticians, and will include financial rewards for participation.
The program will be available to employees in initially 20 of BJ's 200 worksites, and later expanded to 25 worksites.
These worksites have been randomly selected, allowing a randomized controlled trial evaluation of the effects of the wellness program.
Data will be collected on a wide array of outcomes from multiple sources, including on-site biometric screenings and surveys, employment records, and health insurance claims for employees at both treatment and control worksites.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48664
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Employed in one of BJ's clubs during the period of the intervention
Exclusion Criteria:
- Not employed in one of BJ's clubs during the period of the intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Employees at treatment worksites will be given access to workplace wellness programming.
Participation by employees will be voluntary, but all employees at treatment sites will be considered as part of the treatment group.
Employees will also be invited to complete on-site biometric assessments and questionnaires.
Data from secondary data sources (including employment records and health insurance claims) will be collected for employees at all BJ's worksites.
|
Multi-prong workplace wellness program, with components such as nutrition counseling, fitness challenges, and stress management workshops, including supports and incentives.
|
No Intervention: Primary Control
Employees at primary control worksites will be invited to complete on-site biometric assessments and questionnaires, but will not have access to the workplace wellness programming.
Data from secondary data sources (including employment records and health insurance claims) will be collected for employees at all BJ's worksites.
|
|
No Intervention: Secondary Control
Employees at secondary control worksites will not participate in in-person screenings or questionnaires, and will not have access to workplace wellness programming.
Data from secondary data sources (including employment records and health insurance claims) will be collected for employees at all BJ's worksites.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity
Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention
|
Regular exercise, number of hours sitting per day, and actively managing weight, as indicated in responses to survey questions
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
Obesity
Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention
|
Body Mass Index>=30, calculated from measured height and weight
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
Absenteeism
Time Frame: Administrative records from 3 years spanning intervention
|
Number of sick or personal days as a share of total days employed, from employment records
|
Administrative records from 3 years spanning intervention
|
Health care spending
Time Frame: Administrative records from 3 years spanning intervention
|
Dollars spent on health care for employees covered by employer-sponsored insurance, from claims records
|
Administrative records from 3 years spanning intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention
|
Systolic blood pressure, measured
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
Depression
Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention
|
Unmanaged depression, as indicated in responses to survey questions
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
Tenure
Time Frame: Administrative records from 3 years spanning intervention
|
Duration of employment in days, from employment records
|
Administrative records from 3 years spanning intervention
|
Job performance
Time Frame: Administrative records from 3 years spanning intervention
|
Numerical performance rating from annual review, from employment records
|
Administrative records from 3 years spanning intervention
|
Health care spending (i.e. dollars spent)
Time Frame: Administrative records from 3 years spanning intervention
|
Dollars spent on health care and prescription drugs for employees covered by employer-sponsored insurance, decomposed into spending on inpatient, outpatient, emergency department, and prescription drugs, from claims records
|
Administrative records from 3 years spanning intervention
|
Health care utilization (i.e. number of doctor visits, hospitalizations, or medications)
Time Frame: Administrative records from 3 years spanning intervention
|
Health care encounters and prescription drugs for employees covered by employer-sponsored insurance, decomposed into inpatient, outpatient, emergency department, and prescription drugs, from claims records
|
Administrative records from 3 years spanning intervention
|
Nutrition management
Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention
|
Affirmative engagement in active efforts to improve nutrition, as indicated in responses to survey questions
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
Stress management
Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention
|
Unmanaged stress and stress at work, as indicated in responses to survey questions
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
Screenings and exams
Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention
|
Percent of recommended tests received, as indicated in responses to survey questions
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
Tobacco use
Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention
|
Smoking, as indicated in responses to survey questions
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
Health and wellbeing
Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention
|
Short form 8 (SF-8) physical and mental summary scores, as indicated in responses to survey questions.
Each question of the SF-8 uses a 5- or 6-point Likert scale.
Its standardized scoring system combines responses into a score that can be interpreted as a continuous variable (analogous to a 0-100 scale), with higher scores denoting better self-reported health.
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
Blood glucose
Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention
|
Blood glucose, measured
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
Cholesterol
Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention
|
Total cholesterol and high-density lipoprotein (HDL), measured
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Zirui Song, MD, PhD, Harvard Medical School (HMS and HSDM)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
October 1, 2018
Study Completion (Actual)
June 1, 2021
Study Registration Dates
First Submitted
May 23, 2017
First Submitted That Met QC Criteria
May 24, 2017
First Posted (Actual)
May 30, 2017
Study Record Updates
Last Update Posted (Actual)
September 9, 2021
Last Update Submitted That Met QC Criteria
September 7, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wellness 14-3141
- R01AG050329 (U.S. NIH Grant/Contract)
- P30AG012810 (U.S. NIH Grant/Contract)
- 72611 (Other Grant/Funding Number: Robert Wood Johnson Foundation)
- AEARCTR-0000586 (Registry Identifier: American Economic Association Trial Registry)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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